SPECIAL NOTICE
66 -- Laboratory Equipment, Installation, Training, and Extended Warranty
- Notice Date
- 2/14/2011
- Notice Type
- Special Notice
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA-SOL-1084543
- Archive Date
- 3/8/2011
- Point of Contact
- William T. Lee, Phone: 3014435863, Doreen Williams,
- E-Mail Address
-
william.lee@fda.hhs.gov, doreen.williams@fda.hhs.gov
(william.lee@fda.hhs.gov, doreen.williams@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- General Information: Document Type: RFI Release Date: February 14, 2011 Response Date: February 21, 2011 at 10:00 local time via email to william.lee@fda.hhs.gov Contracting Office Address: Food and Drug Administration, 5630 Fisher Lane, Rockville, Maryland 20857; Attn: William Lee, Contract Specialist Description of Services/Supplies: HPLC/Triple Quadrupole Mass Spectrometer; Installation and Training; 2 year Extended Warranty This is a Request for Information (RFI) to identify the capabilities of the marketplace of all interested parties. This request is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the Food and Drug Administration (FDA) for any future solicitation. No official solicitation exists; therefore, please do not request a copy of a solicitation. If in the future an official solicitation is released, there is no guarantee that sources responding to this will be included on the source list. Telephone inquiries will not be accepted. The FDA makes no implied or in fact contract by issuing this RFI. Acknowledgement of receipt of responses will not be made, nor will respondents be notified of the FDA's view of the information received. Do not send any material that requires a non-disclosure agreement or that may be business sensitive. Responses received that include a non-disclosure agreement or identify information that is business sensitive will not be accepted. Responses to this notice will not be returned. According to FAR Part 10, Market Research, the results of the market research will be used to: i) Determine if sources capable of satisfying the agency's requirements exist; (ii) Determine if commercial items or, to the extent commercial items suitable to meet the agency's needs are not available, nondevelopmental items are available that- (A) Meet the agency's requirements; (B) Could be modified to meet the agency's requirements; or (C) Could meet the agency's requirements if those requirements were modified to a reasonable extent; (iii) Determine the extent to which commercial items or nondevelopmental items could be incorporated at the component level; (iv) Determine the practices of firms engaged in producing, distributing, and supporting commercial items, such as type of contract, terms for warranties, buyer financing, maintenance and packaging, and marking; (v) Ensure maximum practicable use of recovered materials and promote energy conservation and efficiency; and (vi) Determine whether bundling is necessary and justified. (vii) Assess the availability of electronic and information technology that meets all or part of the applicable accessibility standards issued by the Architectural and Transportation Barriers Compliance Board at 36 CFR Part 1194. The extent of market research will vary, depending on such factors as urgency, estimated dollar value, complexity, and past experience. The contracting officer may use market research conducted within 18 months before the award of any task or delivery order if the information is still current, accurate, and relevant. Market research involves obtaining information specific to the item being acquired and should include- (i) Whether the Government's needs can be met by- (A) Items of a type customarily available in the commercial marketplace; (B) Items of a type customarily available in the commercial marketplace with modifications; or (C) Items used exclusively for governmental purposes; (ii) Customary practices regarding customizing, modifying or tailoring of items to meet customer needs and associated costs; (iii) Customary practices, including warranty, buyer financing, discounts, contract type considering the nature and risk associated with the requirement, etc., under which commercial sales of the products or services are made; (iv) The requirements of any laws and regulations unique to the item being acquired; (v) The availability of items that contain recovered materials and items that are energy efficient; (vi) The distribution and support capabilities of potential suppliers, including alternative arrangements and cost estimates; and (vii) Size and status of potential sources. Mission and Objectives: FDA anticipates the need for an HPLC/Triple Quadrupole Mass Spectrometer, installation and training and a (2) year extended warranty for quantitation of vaccine components and support anticipated future needs to quantify vaccine impurities. RFI Instructions: Please complete Part A, Specification Questionnaire, describing your company's capabilities; Part B, Size of Business and Part C, Estimated Dollar Value Range. Responses shall be:  identified with the RFI number ;  no more than ten (10) pages in length;  not submit marketing materials;  submitted to the email as indicated above. FDA makes no implied or in fact contract by issuing this RFI. Acknowledgement of receipt of responses will not be made, nor will respondents be notified of the FDA's view of the information received. Part A. Technical Capability Specification Questionnaire: 1) Is your company capable of providing HPLC/Triple Quadrupole Mass Spectrometer, installation and training and a (2) year extended warranty? 2) Does this system meet or exceed the following minimum LC system requirements? o utilize HPLC and sub 2 um column chromatography separations, with ability to use 2 or more columns in sequence or separately o Full HPLC operational capability as well as UPLC capability without hardware such as tubing changes needed. o use an ethernet interface for PC-based software control to operate and switch columns o use a pump that  has the capability of quaternary mixing  has flow accuracy and gradient accuracy equal or better than ± 1% for the entire pressure and flow rate operating range of the pump (measured with water)  has settable range from a gradient between 0 and 100%  has an integrated degassing unit  can be optimized for high-throughput applications o The LC autosampler shall:  be capable of injecting between 1 - 100 μL samples  use multiple sample formats, to include at least 2x 96 or 384-well plate formats  have sample temperature control o The system shall include an analytical-scale fraction collector with:  Delay volumes less than 0.1 mL  Flow rates between 0.1-10 mL/min  Collection containers to include 96 and 384-well plate formats  Full collection trays to accommodate plates, 5 mL test tubes, and eppendorf vials 3) Does this system meet or exceed the following minimum Mass Spectrometer (MS) system requirements? o The instrument shall be a bench-top model o operate in mass range: m/z 10 - 2048 o MRM sensitivity (ESI+) shall be such that at least 1pg on-column injection of reserpine will give a chromatographic signal-to-noise greater than 3000:1. The region of the chromatogram baseline designated as noise will be at least 1 minute in length and end within 30 sec of the first replicate injection. No excluding, processing, or smoothing of the data points used in the calculation of S/N. o Mass resolution shall be automatically adjustable o Mass peak width should be 0.5 Da or better at half maximum height (FWHM) across the entire mass range o Acquire data with adjustable scan speed and equipped with high-speed signal processor o The mass spectrometer shall not use water-cooled turbomolecular pumps o The divert valve shall be under fully automated data system control o The divert valve shall enable the user to switch the solvent front, gradient end point and any other portion of the HPLC run to waste o Allow user to define the default state of the valve "to waste" or "to source" o The instrument shall have a start in/out contact closure o Ionization Modes - ESI and APCI, with ability to switch between modes without need to remove the main source housing. Nanospray must be available as option. o The instrument shall include instrument control and processing software, quantitation package o The system shall support 21 CFR Part 11 compliancy 4) Does this system meet or exceed the following software requirements?  acquire and display full scan mass spectra from Q1 and Q3  acquire and display Selected Ion Monitoring (SIM) scan data for monitoring selected ions for target compound analysis. When desired it should be able to perform automatically selected SIM experiments (based on abundance or m/z) for at least 25 ions  acquire and display Full Scan Product ion spectra  acquire and display Full Scan Precursor ion spectra as well as neutral loss scans  acquire and display Selected Reaction Monitoring (SRM) data for a defined transition  include ability for quantitation using labeled standards as well as label-free methods  Shall be able to acquire a data-depended scan based upon all kinds of scanning preceding survey scans  be able to switch ion polarity of the Data-Dependent scan  have MS/MS (quantitation enhanced by data-dependent MS/MS) feature for sequential quantitation and structure ID confirmation.  include a function to ramp collision energy  be able to switch ion polarity during acquisitions within 20 ms  be able to automatically create SIM and MRM tables during acquisitions  have capability to temporarily exclude an ion while allowing acquisition of MS/MS spectra  provide control software for the LC, pumps, sampler and UV detector  be capable of data acquisitions whereby high- and low-collision energy data is acquired simultaneously to provide fragmentation data for all detectable molecular ions  include software for quantitation using labeled standards as well as label-free methods  shall have an option to support biotech database tools  shall have ability to import MRM tables for peptide fragments from accurate mass MSMS data  shall have ability to acquire MRMs and associated product ion spectra without compromising quantitation of MRM peak integration 5) Does this system meet or exceed the following installation and Training requirements? o Components shall be installed to meet specifications as written in bid response and must be met after any service visits o Users shall be familiarized with the instrument within 6 weeks of delivery o Training shall provide tuition for at least 2 individuals at manufacturer's training site o Training shall include 4 day onsite instruction for 3-5 individuals 6) Does this instrument allow for an extended warranty for 4 years total? If not, what is your customary practice for a warranty for this type of instrument? Part B. Size of Business State whether your company is a large business, small business (and also state your under socioeconomic status), College/University, or a non-profit organization. Part C. Estimated Dollar Value Range Based on the government's mission, objectives, and scope of work, what dollar value range would you determine to be the most accurate rough estimate. Under $150,000.00 Over $150,000.00 and Under $500,000.00 Over $500,000.00 and Under $1,000,000.00
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-SOL-1084543/listing.html)
- Record
- SN02379311-W 20110216/110214234227-de2a7e4e4a92e11342b8a79b1e061a2f (fbodaily.com)
- Source
-
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